Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy

Not Applicable

Completed

• Conditions: Transeversus Thoracic Plane Blocks; Serratus Anterior Plane Block; Modified Radical Mastectomy; Ultrasound-Guided; Pectoral Nerve (PECS) Block
• Interventions: Procedure: Serratus anterior plane (SAP) block; Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block

• Registration Number: NCT04908878
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study Start: 2021-06-01
• Study First Posted: 2021-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Female patients
• Aged 21-60 years
• ASA physical status I, II
• Scheduled for unilateral modified radical mastectomy

Exclusion Criteria

1. Patient refusal.
2. Known hypersensitivity to local anesthetics.
3. Body mass index > 35 kg /m2.
4. Uncooperative or psychiatric patients.
5. Infection at the injection site.
6. Coagulation disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (serratus anterior plane (SAP) block group)	Serratus anterior plane (SAP) block	Patients will receive US-guided SAP block after induction of general anesthesia.
Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group)	Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block	Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.	First 24 hours postoperatively.	Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.

Secondary Outcome Measures

Name	Time	Method
The degree of postoperative pain	First 24 hours postoperatively.	Postoperative pain will be assessed by Visual Analog scale (VAS) on admission to Post-Anesthesia Care unit (PACU) and at 30 minutes and then 1,2,4,6,12,18 and 24 hours postoperative.; VAS (0-100; where 0 represents no pain and 100 represents the worst pain).
Intraoperative fentanyl consumption.	Intraoperative	Additional boluses of fentanyl 0.5 µg /kg will be administered in case of inadequate analgesia that defined as increase of heart rate (HR) and /or mean arterial blood pressure (MAP) more than 20 % from baseline
Time to first rescue analgesia request.	First 24 hours postoperatively.	Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.

Trial Locations

Locations (1)

Faculty of Medicine Tanta University; 🇪🇬 Tanta, Elgharbia, Egypt